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U.S. Department of Health and Human Services

Class 2 Device Recall DRXRevolution

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 Class 2 Recall
DRXRevolution
see related information
Date Posted October 31, 2013
Recall Status1 Open
Recall Number Z-0126-2014
Recall Event ID 65469
Premarket Notification
510(K) Number
K120062 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Code Information Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490
Recalling Firm/
Manufacturer
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608-1733
Manufacturer Reason
for Recall
Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.
FDA Determined
Cause 2
DESIGN: Device Design
Action On June 6, 2013 Carestream Health Inc. initiated a recall for the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health Inc. will replace the power plug in all potentially impacted DRX-Revolution Mobile X-Ray Systems. Your Carestream service representative will contact you to answer any questions and schedule a visit to replace the plug of your Mobile X-Ray System as soon as possible. If you have any questions or concerns, or if you experience any issue with your plug prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time.
Quantity in Commerce 180 units
Distribution Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = CARESTREAM HEALTH, INC.
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